Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated mCSPC

Titre officiel

TALAPRO-3: a phase 3, randomized, double-blind, study of talazoparib with enzalutamide versus placebo with enzalutamide in men with DDR gene mutated metastatic castration-sensitive prostate cancer

Sommaire:

Cette étude a pour but de comparer l’innocuité et l’efficacité du talazoparib pris en association avec l’enzalutamide à celles du placebo en association à l’enzalutamide chez des participants atteints d’un cancer de la prostate hormonosensible métastatique avec déficit en facteurs de réponse aux dommages de l’ADN (RDA).

Description de l'essai

Primary Outcome:

  • radiological Progression-Free Survival
Secondary Outcome:
  • Overall Survival
  • Objective response in measurable soft tissue disease
  • Duration of response in measurable soft tissue disease
  • Prostate Specific Antigen (PSA) response
  • Time to PSA progression
  • Time to initiation of antineoplastic therapy
  • Time to first symptomatic skeletal event
  • Opiate use for prostate cancer pain
  • Incidence of adverse events
  • Pharmacokinetic assessment of talazoparib
  • Pharmacokinetic assessment of enzalutamide and its metabolite
  • Relationship between ctDNA burden and outcome
  • Patient-reported outcomes in pain symptoms - change from baseline
  • Patient-reported outcomes in pain symptoms - time to deterioration
  • Patient-reported outcomes in cancer specific general health status - change from baseline
  • Patient-reported outcomes in cancer specific global health status/QoL - change from baseline
  • Patient-reported outcomes in cancer specific global health status/QoL - time to definitive deterioration
  • Patient-reported outcomes in cancer specific symptoms - time to definitive deterioration
  • Patient-reported outcome: cancer specific functioning, and symptoms - change from baseline
The study will have 5 periods: prescreening, screening, double-blind treatment, safety follow-up, and long-term follow-up. Approximately 550 men with mCSPC will be randomized. Eligible participants will be randomly assigned to either of 2 treatment groups as follows:
  • Talazoparib in combination with enzalutamide.
  • Placebo capsules identical in appearance to talazoparib capsules in combination with enzalutamide. Talazoparib or identical placebo treatment will be blinded. Enzalutamide (160 mg/day) will be open label. The dose of talazoparib/placebo to be given in combination with enzalutamide is 0.5 mg once daily. Participants with moderate renal impairment (eGFR 30-59 mL/min/1.73 m2 by the MDRD equation) at screening may be enrolled and the talazoparib/placebo dose will be 0.35 mg once daily.

Voir cet essai sur ClinicalTrials.gov

Intéressé(e) par cet essai?

Imprimez cette page et apportez-la chez votre médecin pour discuter de votre admissibilité à cet essai et des options de traitement. Seul votre médecin peut vous recommander pour un essai clinique.

Ressources

Société canadienne du cancer

Ces ressources sont fournies en partenariat avec Société canadienne du cancer